ClinicalTrials.gg
RecruitingNCT07468188Updated Mar 12, 2026

Diabetes Body Project 2

An interventional study of Body Project Type 2 in Eating Disorders and Type 2 Diabetes, sponsored by Joslin Diabetes Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Joslin Diabetes Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2025, registered Jan 2026).
  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

The purpose of this study is to test the feasibility and effectiveness of an eating disorder prevention program specifically targeted for women with type 2 diabetes (T2D) called the Diabetes Body Project 2 (DBP2).

The Diabetes Body Project 2 (DBP2) will be adapted from the Diabetes Body Project, which is an eating disorder prevention program developed to improve satisfaction with body image and diabetes management for young women with type 1 diabetes (DBP).

The study is looking to see if the DBP is effective in improving body image concerns, reducing disordered eating behaviors and improving glycemic control in women with T2D.

02

Conditions studied

  • Eating Disorders
  • Type 2 Diabetes
03

In context

Feeding and Eating Disorders

645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.

This study's planned enrollment of 42 is below the median of 71 across 452 interventional studies indexed under Feeding and Eating Disorders.

Browse Feeding and Eating Disorders studies →

Lead sponsor

Joslin Diabetes Center is the lead sponsor of 80 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1.) Female sex 2) self-reported gender identity of "woman"; 3) age 18-40 years old; 4) diagnosed with T2D for at least 6 months; 5) experiencing at least one body image concern.

Exclusion criteria

Exclusion Criteria:

  • Recent hospitalization for eating disorder within the last 12 months
  • Eating disorder related diabetic ketoacidosis within the last 12 months
  • unwillingness to be video-recorded,
  • restricted English proficiency
  • developmental, cognitive, or psychiatric limitations that compromise participation in the intervention sessions and study.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Body Project Type 2 Intervention

    This program consists of weekly 1-hour sessions for 6 weeks, co-led by 2 facilitators. Each session has home exercises. Home exercises are discussed at each session. session 1, collectively define the thin appearance ideal, discuss costs of pursuing this ideal. session 2 dissuade facilitators from pursuing the thin ideal in role-plays. session 3, conduct role-plays challenging thin-ideal statements, discuss personal body image concerns. session 4, the negative effects of social comparison, the advantages and costs of social media. session 5, strategies of living well with diabetes and maintaining good self-care, as well as the physiological and psychological advantages of insulin. session 6 discuss the benefits of the group and what was learned and how to continue some of the exercises introduced in the Diabetes Body Project; participants are encouraged to engage in at least one more self-affirmation exercise and email the facilitators to tell them how it went.

    Behavioral: Body Project Type 2

Interventions

  • BehavioralBody Project Type 2

    This program consists of weekly 1-hour sessions for 6 weeks, co-led by 2 facilitators. Each session has home exercises. Home exercises are discussed at each session. session 1, collectively define the thin appearance ideal, discuss costs of pursuing this ideal. session 2 dissuade facilitators from pursuing the thin ideal in role-plays. session 3, conduct role-plays challenging thin-ideal statements, discuss personal body image concerns. session 4, the negative effects of social comparison, the advantages and costs of social media. session 5, strategies of living well with diabetes and maintaining good self-care, as well as the physiological and psychological advantages of insulin. session 6 discuss the benefits of the group and what was learned and how to continue some of the exercises introduced in the Diabetes Body Project; participants are encouraged to engage in at least one more self-affirmation exercise and email the facilitators to tell them how it went.

06

What researchers measure

Primary outcomes

  1. Intervention refinement

    Development and refinement of diabetes body project intervention script "DBP2" for young women with type 2 diabetes and body image concern

    Time frame: 6 months

Secondary outcomes

  1. Change in Diabetes Eating Problems

    Assess change in score of Diabetes Eating Problem Survey-Revised (DEPS-R). 16-question assessment that evaluates eating and diabetes management over a one month period. Each question is scored on the following scale: 0 (never), 1 (rarely), 2 (sometimes), 3 (often), 4 (usually) to 5 (always). Higher scores indicate more disordered eating.

    Time frame: baseline to 3 months

  2. Eating Disorder Diagnostic Interview (EDDI)

    Participants will complete the Eating Disorder Diagnostic Interview (EDDI) over the phone with the research team. This semi-structured interview is used to assess eating disordered patterns for woman with type 2 diabetes over a year-long period. The interview has 24 questions, each with a unique scoring scale, which is assessed individually by question.

    Time frame: baseline to 3 months

  3. Change in Diabetes Distress

    Assess change in score of Type 2 Diabetes Distress Assessment Scale (T2-DDAS). 29-question assessment that evaluates the stresses and worries of those with type 2 diabetes over a one month period. Each question is scored on the following scale: 1 (not a problem), 2 (a little problem), 3(a moderate problem), 4 (a serious problem), to 5 (a very serious problem). For the first 8 questions, the higher the score the higher intensity of distress. For questions 9-29, scoring is divided into categories to assess sources of distress (hypoglycemia, long-term health, healthcare providers, interpersonal issues, shame/stigma, healthcare access, and management demands). The higher the score per source, the higher the impact of distress on that source.

    Time frame: baseline to 3 months

  4. Change in Weight Bias

    Assess change in score of Weight Bias Internalization Scale (WBIS). 11-item assessment that evaluates perceived weight status at time of survey. Each question is scored on the following scale: 1 (strongly disagree), 2 (disagree), 3 (slightly disagree), 4 (neutral), 4 (usually), 5 (slightly agree), 6 (agree), to 7 (strongly agree). Higher scores indicate more internalized weight bias.

    Time frame: baseline to 3 month

Other outcomes

  1. Change in A1c

    Change in A1c

    Time frame: baseline to 3 months

  2. Change in CGM-derived time in range (TIR)

    Change in CGM-derived time in range (TIR)

    Time frame: Baseline to 3 months

07

Study locations

1 of 1 sites recruiting
  • Joslin Diabetes Center
    Boston, Massachusetts 02215, United States
    Recruiting
    • Christine Slyne · Contact6173094683
    • Elena Toschi, MD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Feb 2027, 25 months after the start.

Of 269 non-industry interventional studies with no phase under Feeding and Eating Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's planned 25 months is below that.

Counting every sponsor, half of 274 studies reached it within 28 months; a quarter within 14 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2026
First posted
Mar 12, 2026
StartActual
Jan 24, 2025
Primary completionEst.
Feb 28, 2027
CompletionEst.
May 31, 2027
Last update
Mar 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07468188
Lead sponsor
Joslin Diabetes Center
Responsible party
Sponsor
First posted
Mar 12, 2026
Start date
Jan 24, 2025
Primary completion
Feb 28, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Mar 12, 2026

Study contacts

Christine Slyne
Contact
christine.slyne@joslin.harvard.edu
6173094683
Molly Savory
Contact
msavory1@joslin.harvard.edu
6173091997

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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